One of the challenges in drug development is making formulations that have a long-lasting therapeutic effect. Implantable products that release a drug slowly over time offer one way to deliver medication for longer than a day, but such long-acting effects have been more difficult to achieve with pills.
Drug delivery startup Lyndra has developed technology that it says can make capsules in extended-release formulations that could go far longer than a day. Now, as the Watertown, MA-based company prepares to test its technology in clinical trials, it has raised $23 million in a Series A round of financing. Polaris Partners led the investment, which included participation from Quark Venture and GF Securities, Yonghua Capital, Healthlink Capital, Partners Healthcare, Suffolk Equity Partners, among others.
Lyndra claims its drug delivery technology is the first that can make pills in ultra-long acting, sustained release formulations.
“We have never seen anyone able to do sustained, oral release longer than 12 to 24 hours,” says Lyndra CEO and co-founder Amy Schulman.
The Lyndra technology has its origins at the MIT laboratories of professor Robert Langer. Schulman says drugs made with the technology can last for a day, a week, or even longer because its drug delivery device stays in the stomach for a longer period of time. Lyndra accomplishes that via a star-shaped device that has the drug loaded onto each of its arms. Folded onto itself, this device fits inside a capsule.
In the stomach, the capsule dissolves, allowing the star to unfurl. That open shape keeps the device in the stomach, releasing its payload slowly rather than passing right through the digestive system the way that pills do. Schulman says that this shape is big enough to keep the device in place but not so big that it obstructs food. The technology is “tunable,” allowing a drugmaker to adjust the delivery of an active pharmaceutical ingredient for an initial burst of the drug followed by a tapered release, or a slow and steady release of the drug over a long period of time.
Schulman says Lyndra’s technology could help address the problem of getting patients to take their medications. The company cites research published in the Archives of Osteoporosis showing that patients do a better job of sticking with their medication regimen if they require less frequent dosing. Lyndra says its technology could be used to make drugs that need to be taken only weekly, perhaps even monthly.
The idea of tinkering with how a pill interacts with the body’s digestive system is not an entirely new one. For example, Pozen, the former Chapel Hill, NC, company, developed a way to make pills that delayed the release of a drug’s active ingredient in the gastrointestinal tract. But the company’s technology, which it applied to previously approved drugs, was meant to offer formulations that were safer on the stomach, not longer lasting.
For now, Lyndra isn’t identifying the drugs or types of drugs it is working with. Schulman says that Lyndra’s drug delivery technology works with many different kinds of drugs and the startup has partnered with pharma companies to work on their already approved products, as well as their experimental drugs still in development.
Lyndra also has its own lead drug program, though the company is keeping those details under wraps. Schulman would only say that the drug is a Lyndra product, not a drug from another pharma company. But she added that the drug is “not necessarily a new molecule.” Schulman says the new funding will support this lead program and help Lyndra increase its manufacturing capabilities. The company plans to start clinical trials by early fall but it’s too early to know for sure which regulatory path the drug will take to secure FDA approval, Schulman says.